In the biotechnology and pharmaceutical manufacturing industries, disposable bags and tubing assemblies are sometimes used in lieu of metallic equipment and piping for aseptic or sterile processing. Disposable bags and tubing assemblies are used because they do not require cleaning or steaming in place as do metallic equipment and piping to maintain cleanliness and/or sterility. The disposable components are preferred because they can be sterilized via gamma-irradiation and discarded after use.
To date, an efficient disposable method for heating or cooling cell culture or protein purification process fluid does not exist. Large jacketed disposable bag holders or stainless steel heat exchangers are typically used. In many cases, temperature is not well controlled causing quality or yield issues.
Accordingly, it is an object of the present invention to provide an improved method and apparatus for heating or cooling cell culture or protein purification process fluid.
Another object of the present invention is to provide a disposable heat exchanger system integrating a sterile disposable bag assembly with a heat exchanger manifold assembly.
Still another object of the present invention is to provide an improved method and apparatus that in accordance with the foregoing objects and that provides enhanced quality and yield in cell culture and protein purification applications.